MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC INFINION CX LEAD; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number INFINION CX LEAD

Device Problems Fracture (1260); High impedance (1291); Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 06/23/2021

Event Type  Injury  

Event Description

Boston scientific infinion cx lead fracture for spinal cord stimulation; this is the most recent patient.I have multiple other patients with the same type of fracture requiring re-operation.Left lead fractured 2 inches before anchor.Low test range: ap and lateral fluoro view; high test range: high impedence of all 16 leads with programming.Patient loses coverage and over time the contacts all (16) have high impedence.Multiple patients with the same problem and all 0-3 years after implant.No other lead from boston has this problem.Other companies: medtronic, abbott, nevro do not have this problem in my practice.Fda safety report id # (b)(4).

• Brand Name: BOSTON SCIENTIFIC INFINION CX LEAD
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION ; philadelphia PA 19178 6205
• MDR Report Key: 12075270
• MDR Text Key: 258954904
• Report Number: MW5102165
• Device Sequence Number: 1
• Product Code: LGW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: INFINION CX LEAD
• Device Lot Number: 7070809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 76